Abstract

STUDY OBJECTIVE:

To determine whether rosiglitazone is associated with the onset or worsening of chronic heart failure (CHF) when administered to patients with type 2 diabetes mellitus who receive insulin.

DESIGN:

Retrospective cohort analysis.

SETTING:

Veterans Affairs medical center.

SUBJECTS:

One hundred thirty-nine patients who received insulin for treatment of type 2 diabetes mellitus and had rosiglitazone added to their drug regimens.

INTERVENTION:

Medical records were reviewed for 6 months before and 6 months after each patient's first rosiglitazone prescription. Records were assessed for the diagnosis of CHF and documented patient complaints of CHF symptoms requiring a medical intervention (unscheduled primary care or emergency room visit, start or dosage adjustment of CHF pharmacotherapy, or hospitalization).

MEASUREMENTS AND MAIN RESULTS:

A diagnosis of CHF was documented in Thirty-five (25%) patients in the preindex period (before receiving rosiglitazone) versus 42 (30%) in the postindex period (after receiving rosiglitazone). Fifty (36%) patients received a medical intervention for CHF signs or symptoms in the postindex period compared with only 20 (14%) in the preindex period (p<0.0001). Of the 50 patients requiring a medical intervention in the postindex period, 33 (66%) had not required an intervention in the preindex period. The most common symptom was lower extremity edema; this occurred in 25 (18%) patients in the preindex period and 50 (36%) patients in the postindex period (p<0.0001).

CONCLUSION:

More patients were diagnosed with CHF during the 6 months after rosiglitazone was added to their drug regimens than in the previous 6 months, when these patients received insulin but not rosiglitazone. In addition, more medical interventions related to CHF occurred after administration of rosiglitazone. Data from this study appear to support the Food and Drug Administration's warning of an increased risk of cardiac failure in patients receiving concurrent treatment with rosiglitazone and insulin.